In todayâ€™s Wall Street Journal there is a fantastic opinion piece written by Dr. Mark Thornton,
Black Wednesday at the FDA. Dr. Thornton points out that not only did the FDA not approve Provenge last Wednesday, but also it failed to approve Junovan, a immunological drug designed to treat young children with a rare bone cancer called osteosarcoma!
Neither drug was approved because of statistical â€œissues.â€ What is even more remarkable, the statistical issue with Junovan was its failure to reach the FDA benchmark for efficacy, which is a 95% chance of surety that the drug caused the improvement in the children. You see, Junovan only reach a 94% rate so it was not approved! Even though there was only 1% difference, the committee voted 12 to 2 not to approve this immunotherapy!
Efficacy rates and the statistical analysis are certainly important in guaranteeing that our drugs and treatments do perform as claimed by the bio tech companies and pharmaceuticals. However, not all drugs and treatments are equal and they should not be evaluated using the same criteria. Immunotherapy is not chemotherapy and the differences must be adjusted for in how we evaluate efficacy.
Last Wednesday not only did the FDA strike a blow against older men, it also struck a blow against our most vulnerable, our children. All I can say is shame on them and shame on us for allowing this to have happened.
(Dr. Thornton, a former medical officer in the FDA Office of Oncology Products, volunteers as president of the Sarcoma Foundation of America)
Joel T. Nowak, MA, MSW